Diet Changes for Depression

Overseen By Ashley Gearhardt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Lithium

Disqualifiers: Diabetes, Bipolar, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study experimentally investigates 1) whether ultra processed food (UPF) intake contributes to depression by increasing low mood and poor sleep due to blood glucose fluctuations (which then increases the desire to consume more UPFs) and 2) to investigate the effectiveness of a 2-week meal-kit intervention that provides convenient and tasty minimally processed foods (MPF) to reduce depression. The following aims and hypotheses are tested: Aim 1: To investigate whether UPF intake and low mood contribute to each other in a cyclical fashion through the mechanisms of blood glucose fluctuations and disrupted sleep in individuals with moderate-to-severe depression. H1: It is hypothesized that UPF intake and high blood glucose will be associated with low mood in individuals with depression. Aim 2: To establish an industry partnership to investigate whether commercially available meal kit delivery reduces symptoms of depression in individuals with moderate-to-severe depression relative to a nutrition education control condition. H2: Meal kit delivery will lead to reductions in depression symptoms and daily reductions in low mood relative to the control condition (nutrition guidance only).

Are You a Good Fit for This Trial?

This trial is for individuals with moderate-to-severe depression. It explores the relationship between eating ultra-processed foods (UPFs), mood, and sleep, as well as testing if a 2-week meal-kit of minimally processed foods can help reduce depression symptoms.

Inclusion Criteria

Willing to follow dietary guidelines

I can join a consent call via Zoom or phone.

Must own an Android or iPhone smartphone

Exclusion Criteria

Current pregnancy, breast-feeding, trying to get pregnant, or within six months of having given birth

I have taken medication for severe mental health conditions.

I was diagnosed with an eating disorder like anorexia or bulimia in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants complete questionnaires, interviews, and body composition measurements; remote tasks are completed while eating their typical diet

1 week

1 visit (in-person), remote tasks

Dietary Intervention

Participants are randomly assigned to a meal delivery or control condition; complete remote tasks while following dietary guidance

2 weeks

1 visit (in-person), remote tasks

Post-Intervention Assessment

Participants complete questionnaires, interviews, and body composition measurements

1 day

1 visit (in-person)

Follow-up

Participants are contacted to complete a short follow-up survey and provide information about their current diet

6 months

Remote assessments at 1 month and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Low UPF Diet

Trial Overview Participants will either follow a self-guided low UPF diet or receive a study-provided low UPF diet through meal kits. The goal is to see if these diets can improve mood and sleep by stabilizing blood glucose levels, thereby reducing depression symptoms.

How Is the Trial Designed?

Group I: Nutritional Guidance Experimental Treatment 2 Interventions

Dietary change (nutritional guidance) Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following week comprise the dietary intervention period. Nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet. Participants are delivered a box of snacks consistent with a low UPF diet. Visit 3 comprises post-intervention assessment. All participants will complete remote assessments at 1 month and 6 month follow ups.

Group II: Meal Delivery Experimental Treatment 2 Interventions

Dietary change (low ultra-processed meal delivery) and nutrition guidance to follow a low UPF diet. All participants complete a series of three in-lab visits with remote data collection: Visit 1 and the following week comprise the baseline assessment period. Visit 2 and the following 2 weeks comprise the dietary intervention period. Meal delivery and nutritional guidance is provided by the study team for 14 days in accordance with a low UPF diet. Visit 3 comprises post-intervention assessment All participants will complete remote assessments at 1 month and 6 month follow-ups.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+